Symetis SA

Symetis SA

May 18, 2011 06:23 ET

Symetis reports on trans-apical ACURATE TA™ clinical development

- First-in-man data on 40 patients at 6 months

- CE mark 75-patient enrolment completed

LAUSANNE, SWITZERLAND--(Marketwire - May 18, 2011) - Symetis SA, a private Swiss company developing innovative transcatheter aortic valve implantation (TAVI) systems, announced today during the Late-Breaking Trials session at EuroPCR 2011 in Paris the 6-month results of its ACURATE TA™ first-in-man (FIM) clinical study. In addition, Symetis reported having enrolled a total of 75 patients in its FIM and Pilot studies, sufficient to support the filing of its ACURATE TA™ CE mark application.

Details of the study

The study - the largest 2nd generation TAVI FIM study ever - was conducted at 5 sites in Germany: Herzzentrum Leipzig, Kerckhoff-Klinik Bad Nauheim, Universitätsklinikum Freiburg, Westdeutsches Herzzentrum Essen and Universitäres Herzzentrum Hamburg. Forty (40) patients with severe aortic stenosis were recruited and treated with ACURATE TA™. The average age of treated patients was 83 years, with a mean Logistic EuroScore of 21.5% and STS Score of 9.0%.

Results

At 6 months, this novel 2nd generation transapical TAVI demonstrated an 87.5% survival rate, a PV Leak rate of 0 – 1 in 97% of followed patients and functional improvement from baseline in 90% of the cases with a NYHA Class I/II. At 6 months the pacemaker rate remained at 5%.

In addition, with 35 patients enrolled as of today in its Pilot study, Symetis has completed the total enrollment needed for its CE mark filing, which will occur in July. Market approval in Europe is expected by the end of 2011. The company also expects to begin enrollment in the FIM study of ACURATE TF™, its transfemoral system, during Q4 2011.

Dr. Joërg Kempfert of Kerckhoff-Klinik Bad Nauheim commented: "These 6-month data confirm that ACURATE TA™ is a promising alternative to products already on the market."

Laura Brenton, VP Clinical / Regulatory Affairs, added: "The future of the ACURATE TA™ is bright with its comparable 6-month survival, low PV leak and increased functional improvement from baseline compared to recently published related data."

Jacques R. Essinger, CEO of Symetis, stated: "We are very appreciative of our outstanding physicians who supported the clinical development of ACURATE TA™. We are looking forward to bringing this effective product to the market and further expanding our presence in the transfemoral arena."

About Symetis

Symetis SA (www.symetis.com) is a private Swiss company developing innovative, minimally invasive heart valve replacement solutions. The company's products, ACURATE TA™ and ACURATE TF™, based on proprietary geometry and delivery technologies, are well positioned to target the estimated $2 billion TAVI market. Based in Lausanne, the company is financed by leading European venture capital firms, including Truffle Capital, Novartis Venture Fund, Wellington Partners, Aravis Venture, Vinci Capital, Banexi Ventures, Endeavour Vision, NBGI Ventures and BiomedInvest.

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